Arcturus Therapeutics Holdings Inc. ARCT
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a respiratory drug developer. Its lead program, LUNAR-CF (ARCT-032), is in Phase 2 for Cystic fibrosis. Its next catalyst on record is LUNAR-CF (ARCT-032): Completion of fourth cohort enrollment (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: LUNAR-CF (ARCT-032) — Completion of fourth cohort enrollment (2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| KOSTAIVE | COVID-19 | RNA (sa-mRNA) | Approved |
| LUNAR-CF (ARCT-032) | Cystic fibrosis | RNA (mRNA) | Phase 2 |
| LUNAR-OTC (ARCT-810) | Ornithine transcarbamylase (OTC) deficiency | RNA (mRNA) | Phase 2 |
| ARCT-2304 | Pandemic influenza (H5N1) | RNA (sa-mRNA) | Phase 1 |
| ARCT-2601 | Ornithine transcarbamylase (OTC) deficiency | RNA (mRNA) | Pre-clinical |
| LUNAR 2.0 PKU program | Phenylketonuria | RNA (mRNA) | Pre-clinical |
| LUNAR 2.0 Gout program | Gout | RNA (mRNA) | Pre-clinical |
| Seasonal influenza vaccine | Influenza | RNA (sa-mRNA) | Pre-clinical |
| RSV vaccine | Respiratory syncytial virus | RNA (mRNA) | Pre-clinical |
| EBV vaccine | Epstein-Barr virus | RNA (mRNA) | Pre-clinical |
Recent results and decisions
- Sep 30, 2026positive ARCT-810 Phase 2 interim data presented in September showed meaningful biomarker activity and favorable safety profile at 0.3 mg/kg and 0.5 mg/kg doses.
ARCT-810 at 0.3 mg/kg and 0.5 mg/kg demonstrated meaningful biomarker activity, reducing and/or maintaining first-morning fasting ammonia within the normal range, including during increased protein intake, and reducing glutamine levels in all participants.
Filing - Aug 6, 2026completed enrollment ARCT-810 Phase 2 OTC deficiency study completed enrollment and all subjects completed study drug dosing.
ARCT-810, an mRNA therapeutic candidate for OTC deficiency, has completed enrollment of the ongoing Phase 2 study, and all enrolled subjects have completed study drug dosing.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 respiratory companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.